Sr. Compliance Monitoring Specialist
Job Summary
To support the BIOS Clinical Trials Coordinating Center, the full-time Sr. Compliance Monitoring Specialist will lead compliance monitoring for large, multi-centered clinical trials, ensuring data quality and regulatory adherence through a risk-based, remote monitoring approach.
Key responsibilities
- Manage site and study progress by tracking regulatory submissions, recruitment, and data query resolution
- Develop standard and protocol-specific forms and monitoring plans based on risk assessments
- Verify informed consent and the accuracy of trial records and CRFs while communicating deviations from protocols and regulatory requirements
Required qualifications
- Bachelor's Degree
- Five years of related experience with clinical trials or medical research
- Thorough knowledge of ICH GCP and FDA guidelines
- Experience using electronic data capturing systems
- Strong attention to detail in clinical trial data and regulatory compliance review
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